Process Development SME- Bothell, WA (REF9118J)

Job Description

Client is looking for a technical resources to help develop and execute CAPA plans for client specific deviations. Will require SME's with biotech manufacturing/process development expertise.Resource would also carry out the following duties and responsibilities:

• Handling Deviation and Investigation support backlog
• Handling overdue CAPA support
• Writing required deviations
• Writing required CAPA's
• We need candidates who has experience in Micro, Utilities, operations/ utilities/Facility investigation background.

Qualifications

Qualified candidates must have:

• You have an academic degree or equivalent work-related experience in quality management at a pharmaceutical company, a contract-manufacturing organization or a medical device manufacturer.
• Large Molecule experience or background.
• Previous experience in a GMP/FDA regulated work environment.
• Possess an Analytical/Quality Control laboratory background.
• Have prior experience in deviation writing, experience with tools and techniques for root cause analysis

Additional Information

All candidates must be legally eligible to work in the United States.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.